Copenhagen, Denmark – Zealand Pharma A/S, a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon for the prevention...
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BIRMINGHAM, Ala. – The University of Alabama at Birmingham startup TIXiMED, Inc., has obtained clearance from the U.S. Food and Drug Administration to proceed to clinical trials under an Investigational New Drug for TIX100, its novel oral Type 1 diabetes drug. This represents a major milestone in the development of...
TARRYTOWN, N.Y. — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first results for the investigational ubamatamab in patients with low-grade serous ovarian cancer (LGSOC). The data are from an ongoing Phase 1/2 trial in recurrent platinum-resistant high- or low-grade serous ovarian cancer that were presented in a late-breaking plenary...
San Diego, Calif. – UC San Diego Health is the first health system in San Diego County to offer a new bladder-saving gene therapy to treat localized bladder cancer. The novel treatment is the first and only FDA-approved gene therapy delivered directly into the bladder for non-muscle-invasive bladder cancer (NMIBC)....
San Francisco, Calif. – In a discovery that opens the door to a less invasive way of treating some serious disorders before birth, UC San Francisco scientists have found that delivering medicine through amniotic fluid is as effective as delivering it to the fetal brain via cerebrospinal fluid. The experiment...
San Francisco, Calif. – Combining testosterone-blocking drugs in patients with prostate cancer relapse prevents the spread of cancer better than treatment with a single drug, a multi-institution, Phase 3 clinical trial led by UC San Francisco researchers has found. The approach can extend the time between debilitating drug treatments without...
Dapirolizumab pegol (DZP) showed efficacy across multiple clinical endpoints in the PHOENYCS GO study, including fatigue and measures of disease activity DZP showed consistent improvements in fatigue, a common and debilitating symptom of systemic lupus erythematosus (SLE) At Week 48, more individuals receiving DZP experienced no or low disease activity...
ATLANTA, GA — UCB, a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for BIMZELX® (bimekizumab-bkzx), an IL-17A and IL-17F inhibitor, for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS). In addition, a second sBLA...
ATLANTA, Georgia — UCB, a global biopharmaceutical company, today presented positive efficacy and safety results from the GEMZ phase 3 study investigating adjunctive fenfluramine (FFA) in children and adults with CDKL5 deficiency disorder (CDD) at the American Epilepsy Society (AES) meeting in Atlanta, December 5-9, 2025.1 The trial met its primary endpoint and...
ATLANTA — UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that it will be presenting results from across its portfolio in generalized myasthenia gravis (gMG) at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) annual meeting and the Myasthenia Gravis Association of America Scientific Session taking place...